Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Palo Alto Medical Foundation
Information provided by (Responsible Party):
Gladys Block, Berkeley Analytics, Inc.
ClinicalTrials.gov Identifier:
NCT01479062
First received: November 22, 2011
Last updated: August 27, 2014
Last verified: August 2014

November 22, 2011
August 27, 2014
February 2014
October 2015   (final data collection date for primary outcome measure)
  • Change from baseline in body weight [ Time Frame: at 3 months, 6 months and one year ] [ Designated as safety issue: No ]
    Mean weight loss and the proportion of subjects who achieve a 5% body weight loss at 3 and 6 months and maintain at 12 months
  • Change from baseline in diabetes risk markers [ Time Frame: at 3 months, 6 months and one year ] [ Designated as safety issue: No ]
    Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months
  • Change from baseline in body weight [ Time Frame: at 3 months and one year ] [ Designated as safety issue: No ]
    Mean weight loss and the proportion of subjects who achieve a 5%, 7% and 10% body weight loss at 3 months and maintain at 12 months
  • Change from baseline in diabetes risk markers [ Time Frame: at 3 months and one year ] [ Designated as safety issue: No ]
    Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic
Complete list of historical versions of study NCT01479062 on ClinicalTrials.gov Archive Site
Change from baseline in physical activity and dietary factors [ Time Frame: 3 months and 12 months ] [ Designated as safety issue: No ]
Extent of change in physical activity and dietary factors as reported in questionnaires
Same as current
Not Provided
Not Provided
 
Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics
Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)

The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Pre-diabetes
  • Diabetes
  • Obesity
  • Behavioral: Alive-PD
    Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
  • Behavioral: Usual Care
    Placebo Control
  • Experimental: participation in Alive-PD
    Alive-PD lifestyle intervention with multi-channel delivery
    Intervention: Behavioral: Alive-PD
  • Placebo Comparator: Control
    Usual care
    Intervention: Behavioral: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
268
December 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • at least one measurement in past 2 yrs of fasting plasma glucose of 100-125 mg/dl or impaired glucose tolerance
  • at least one measurement of body mass index (BMI) >=27 in the past two years
  • age 40-79
  • no use of diabetes medications within the past two years
  • member of Kaiser Permanente of Northern California (KPNC) for at least 2 years
  • live in a 25 mile radius of the KPNC Research Clinic in Oakland, CA

Exclusion Criteria:

  • comorbidities that would contraindicate the gradual adoption of light/moderate physical activity, such as a recent cardiovascular event, severe chronic obstructive pulmonary disease, advanced arthritis, or poorly controlled hypertension
Both
40 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01479062
1R44NR012617-01
No
Gladys Block, Berkeley Analytics, Inc.
Berkeley Analytics, Inc.
Palo Alto Medical Foundation
Principal Investigator: Gladys Block, PhD Berkeley Analytics, Inc.
Berkeley Analytics, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP